GE Healthcare LOGIQ F R3 Ultrasound System Incorrect Fetal Weight Data Display
GE Healthcare is recalling the LOGIQ F R3 ultrasound system because it may display previous obstetric patient data in fetal weight measurements, potentially leading to incorrect clinical decisions about fetal size and growth.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving medical measurement data display that could lead to incorrect clinical decisions in obstetric care. Although no injuries or illnesses have been reported, the risk of patient harm through erroneous clinical decision-making based on inaccurate fetal growth data meets the High severity threshold.
Plain-English summary
GE Healthcare has recalled the LOGIQ F R3 and Versana Premier R3 series ultrasound systems due to a software issue affecting the Estimated Fetal Weight (EFW) measurement feature. The systems can display previous obstetric patient data in the Whizz report, which could result in inaccurate fetal size and growth calculations.
This data display error could potentially lead to incorrect clinical decisions based on the inaccurate measurement information. The affected devices were distributed worldwide. GE Medical Systems China Co., Ltd. is the manufacturer.
Healthcare facilities and clinicians using affected units should contact GE Healthcare for guidance on remediation options. The specific affected serial numbers are listed with the device documentation and UDI information.
The recalled product
- Product
- GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- data-display-error
- incorrect-measurement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00195278722430
- Lot/Serial Numbers: 6310028WX0
- 6310008WX0
- 6310041WX0
- 6310017WX0
- 6310031WX0
- 6310044WX0
- 6310024WX0
- 6310038WX0
- 6310040WX0
- 6310019WX0
- 6310018WX0
- 6310023WX0
- 6310033WX0
- 6310012WX0
- 6310026WX0
- 6310020WX0
- 6310032WX0
- 6310014WX0
- 6310021WX0
Distribution
Distribution scope not specified by the agency.
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